Status:
COMPLETED
eSTEP: An Integrated mHealth Intervention to Engage High-risk Individuals Along the Full PrEP Care Continuum
Lead Sponsor:
San Diego State University
Collaborating Sponsors:
University of California, San Diego
Conditions:
Pre-Exposure Prophylaxis (PrEP)
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
The long-term goal of this research is to develop a theoretically grounded, effective, accessible and sustainable mHealth PrEP care continuum intervention for racially/ethnically diverse transgender w...
Detailed Description
Study Design: The investigators propose to evaluate the feasibility, acceptability, and preliminary impact of eSTEP in a pilot RCT with transgender women (TW) and gay, bisexual, and other men who hav...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Assigned male sex at birth
- Current male \& GBMSM identity OR transfeminine (woman, transgender woman, or non-binary) identification
- Self-reported HIV-negative status
- English-speaking (since the pilot intervention will be developed in English)
- Owner of an Android or iPhone mobile device and access to this phone during the 6-month study.
- Willingness and ability to attend HIV prevention visits at the HIV treatment and prevention clinic.
- Consent to allow study team access to study-relevant PHI
- Eligible for PrEP following CDC guidelines (in the past 6 months had a sexual partner with HIV with unknown or detectable viral load, inconsistently used condoms, and/or was diagnosed with a sexually transmitted infection)
- Has never used PrEP or has not used PrEP in the past 3 months
Exclusion
- Was a Community Advisory Board Member or participant in the eSTEP focus groups
- Assigned female or intersex at birth
- Living with HIV
- Already taking PrEP
- Under 18 years old
- Does not own a mobile phone
- Does not speak or read English (since the pilot intervention will be developed in English)
Key Trial Info
Start Date :
April 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2025
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT06159582
Start Date
April 3 2024
End Date
June 30 2025
Last Update
September 11 2025
Active Locations (1)
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1
San Diego State University - Department of Psychology
San Diego, California, United States, 92120